DDW: GI Bypass Sleeve Cuts HBA1c in Obese Diabetics

Action Points

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

﻿Explain that a thin polymer sleeve (Endobarrier) anchored in the duodenum of obese patients with type 2 diabetes led to substantial weight loss and normalized glucose levels, but without the morbidity associated with bypass surgery.

Note that the device, which mimics the effect of bariatric surgery by preventing contact of chyme with the duodenal mucosa, has been implanted in more than 500 patients worldwide.

CHICAGO -- A thin polymer sleeve (Endobarrier) anchored in the duodenum of obese patients with type 2 diabetes led to substantial weight loss and normalized glucose levels, but without the morbidity associated with bypass surgery, researchers reported here.

In a small, prospective, open-label study, patients lost an average of 20.4 kg (45 lb; P<0.001 versus baseline) at a year of follow-up, according to Bruno C. Martins, MD, of the University of São Paulo in Brazil, and colleagues.

Moreover, their glucose levels fell from a mean of 175.6 mg/dL to 126.7 mg/dL (P<0.0001) and glycosylated hemoglobin from 8.8% to 6.4% (P<0.0001), Martins and colleagues reported at Digestive Disease Week.

The device, which mimics the effect of bariatric surgery by preventing contact of chyme with the duodenal mucosa, has been implanted in more than 500 patients worldwide so far, Martins said in a press briefing.

To see if the duodenal-jejunal bypass liner might also help control type 2 diabetes in obese patients, the investigators enrolled 22 patients ages 18 and older.

All had been unsuccessful in previous attempts to lose weight. Their mean body weight was 119.2 kg (263 lb), mean BMI was 44.8, and mean hemoglobin A1c was 8.9%, according to Martins.

A total of 17 of the patients were on diabetes medications.

Implantation of the device took slightly over 20 minutes with the patient under general anesthesia.

In nine cases the sleeve was removed because it had shifted position or the patient reported pain, nausea or vomiting, or gastrointestinal hemorrhage occurred. The device was removed endoscopically in about seven minutes with the patient under conscious sedation in all these cases.

The device has now been improved and is more stable, Martins said.

At one year, the 13 patients who remained in the study had a 35.3% weight loss (P<0.0001) and a decrease of 10.1 cm (4 in.) in waist circumference (P=0.0001).

In addition, almost 20% of patients no longer were taking diabetes medications.

There also were benefits in metabolic parameters, with decreases in insulin (P=0.02), C-peptide (P=0.15), total cholesterol (P=0.001), LDL cholesterol (P=0.01), and triglycerides (P=0.006).

In the press briefing, John M. Morton, MD, of Stanford University in Palo Alto, Calif., noted that despite the fact that some 15 million people in the U.S. are eligible for bariatric surgery, only about 200,000 are being done each year.

"The big question is why this need is not being met," he said.

"Some reasons might be stigma or access to care issues, but there also might be patient concerns about surgery, so a device with less morbidity like this is definitely of interest," he said.

"I like to think of an analogy with heart disease. When we first started to treat heart disease it was all surgery, like it's been with obesity in recent years. Now we have stents for the heart and other approaches, so this might have a similar adjunctive role," said Morton, who was not involved in the study.

Martins stated, "We can conclude that through one year of use, the duodenal-jejunal bypass liner has an acceptable safety profile, promotes weight loss, and controls glucose. Nevertheless, we need further studies to confirm these data."

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